Kornimate/medical-research-clean huggingface dataset:
distress tolerance treatment for substance users

Conditions: Substance Dependence

Summary: despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. previous research indicates that an individual's ability to withstand psychological distress is a key factor necessary to maintain drug and alcohol abstinence and to remain in substance use treatment without absconding. in previous work, dr. bornovalova developed a specific distress tolerance treatment called skills for improving distress intolerance (sidi). this intervention features skills training in behavioral and acceptance strategies and intentional clinical exposure to emotional distress. sidi was developed and piloted with a sample of urban drug users seeking treatment in a residential facility. individuals receiving sidi exhibited greater improvement in distress tolerance than those in two comparison groups (receiving treatment-as-usual and supportive counseling). current study. the investigators received nida funding to conduct a randomized clinical trial with 325 clients entering a residential substance use treatment facility. study participants will be randomized into two treatment groups: (1) those receiving sidi and (2) those receiving supportive counseling (sc). participants will receive 10 treatment sessions over a period of 4 months. then, the investigators will follow clients for one year to examine treatment retention and abstinence.


Eligibility criteria:
inclusion criteria: * 18-65 years of age * not evidencing severe cognitive deficits * ability to give informed consent exclusion criteria: * \ 65 years of age * not evidencing severe cognitive deficits (site designation of 'not competent to stand trial') * unable to give informed consent
validation of a pediatric-specific abstinence syndrome assessment tool

Conditions: Substance Withdrawal Syndrome

Summary: the purpose of this study is to assess the validity and reliability of an abstinence syndrome assessment tool used in pediatric patients with iatrogenic opioid dependence.

none available.

Eligibility criteria:
inclusion criteria: * pediatric intensive care unit patients ages 2 weeks to 18 years * patients receiving continuous opioid infusions for 5 days (at least 120 hours) or more exclusion criteria: * attending discretion * patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation

Keywords: abstinence syndrome symptoms withdrawal symptoms opioid dependence
staples versus dermabond for closure of the skin after cesarean section

Conditions: Cesarean Section Wound

Summary: two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). another method of closure is dermabond- liquid skin adhesive. this method of closure is used less frequently than either staples or sutures. few studies have been done regarding whether dermabond is preferable or affect the outcome of a cesarean section surgery. the aim of our study is to find weather dermabond haas better result for the closure of cesarean section wounds.


Eligibility criteria:
inclusion criteria: woman over 18 year woman having elective caesarean section exclusion criteria: age under 18 woman having an emergency caesarean section
recruitment of patients through invitation letters

Conditions: Recruitment, Invitation Letters, Patients With Schizophrenia

Summary: recruitment of patients with schizophrenia to clinical trials is difficult and in an ongoing project different methods of recruitment have been used in order to recruit. one of the methods used have been sending potential participant to the study an invitation letter with information of the study and an invitation to make contact with a project nurse. not many patients have replied. the aim of this study is to examine whether a simplified version of the invitation letter, in terms of information structure and written style will encourage more patients to make contact to a project nurse.

it is found that patients suffering from schizophrenia have a positive attitude concerning participation in a research project but this doesn't always lead to recruitment. this might be due to schizophrenia being a disease causing self-disturbances in communication and contact to the surrounding world. it may lead to vulnerability in decision-making an a lower decision making capacity. language disability is one of the most notable cognitive deficits in patients suffering from schizophrenia and can be devided in to main components of usage and comprehension. patients experience poorer listening comprehension and reading comprehension with no correlation to either age or education level and studies have shown that patients with schizophrenia have low literacy. therefore the aim of this study is to examine whether a rewritten version of an invitation letter, taking in consideration patients low literacy and therefore written in simple sentences and with a sequential structure of information will make more patients take contact to a project nurse compared to patients receiving the original invitation letter. the study design is a randomized controlled trial testing the old letter against the new letter.

Eligibility criteria:
inclusion criteria: * \>18 years * patients with a diagnosis within the spectre of schizophrenia (f-20 to f-25) for at least ten years * at the time of recruitment, a diagnosis of either f-20 or f-25 ( all diagnoses from icd-10) * recidency in the northern part of jutland * in treatment by an outpatient team * low frequency of contact with a clinician, once a month at the most exclusion criteria: * no exclusion criteria for receiving an invitation letter

Keywords: recruitment invitation letter patients schizophrenia
optiflow® to prevent post-extubation hypoxemia after abdominal surgery (the opera trial)

Conditions: Postoperative Hypoxemia

Summary: to evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a pao2/fio2 ratio \<300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

postoperative hypoxemia complicates between 30 to 50% of patients after abdominal surgery. loss of functioning alveolar units and development of atelectasis after abdominal surgery have been recognized as the underlying mechanisms responsible for postoperative hypoxemia. supplemental oxygen administration is therefore widely recommended after extubation in the postoperative period, especially in patients with high risk of postoperative respiratory complications. although oxygen therapy is effective in preventing the vast majority of severe postoperative hypoxemia after extubation in surgical patients, respiratory failure may occur, thus requiring endotracheal intubation and mechanical ventilation or therapeutic use of non-invasive positive pressure ventilation (nppv). in patients with postoperative hypoxemia (defined as patients with a pao2/fio2 ratio \<300), application of nppv was found to decrease the incidence of endotracheal intubation after abdominal surgery. nevertheless, use of nppv in the postoperative period is responsible for organizational constraints and increases healthcare utilization. nasal high flow cannula (nhfc) has been described as an attractive and well-tolerated method of non-invasive oxygen delivery. previous studies have shown that nhfc generates a low level of positive airway pressure, increases end-expiratory lung volume and reduces airway resistance, thus contributing to a reduction in work of breathing. to date, however, no clinical trials have compared nhfc to standard oxygen therapy in the prevention of postoperative hypoxemia after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications. the primary objective of the study is to compare: 1- standard oxygen therapy; 2- nasal high flow oxygen therapy after extubation in patients with intermediate to high risk of postoperative pulmonary complications after abdominal surgery. our hypothesis is that, compared with standard oxygen therapy, early application of nasal high flow oxygen therapy can reduce the need for postoperative nppv for postoperative hypoxemia (defined as pao2/fio2 ratio \<300).

Eligibility criteria:
inclusion criteria: * planned or unplanned surgical procedures * abdominal or abdominal and thoracic surgery * expected duration ≥2 hours * ariscat score ≥26 points exclusion criteria: * age \<18 years * body mass index \>35 kg/m2 * sleep apnea syndrome * patient refusal * pregnancy and/or lactation

Keywords: postoperative pulmonary complications oxygen therapy nasal high flow oxygen therapy nasal high flow cannula
deep learning radiogenomics for individualized therapy in unresectable gallbladder cancer

Conditions: Gallbladder Cancer

Summary: the goal of this observational study is to learn about deep learning radiogenomics for individualized therapy in unresectable gallbladder cancer. the main questions it aims to answer are: (i) whether a deep learning radiomics (dlr) model can be used for identification of her2status and prediction of response to anti-her2 directed therapy in unresectable gbc. (ii) validation of the deep learning radiomics (dlr) model for identification of her2 status and prediction of response to anti-her2 directed therapy in unresectable gbc. participants will be asked to 1. undergo biopsy of the gallbladder mass after a baseline ct scan 2. based on the results of the biopsy, patients will be given chemotherapy either targeted (if her2 positive) or non-targeted 3. response to treatment will be assessed with a ct scan at 12 weeks of chemotherapy

this study aimed at investigating the treatment option for patients with unresectable gb cancer. presently the treatment of unresectable gb cancer mainly palliative with chemotherapy regime limited to generic form of chemotherapy offer to patients with other gi cancer. there is evolving data regarding the role of genetic mutation in cancers. recent studies have also shown multiple somatic and germline mutation in gb cancer. some of these mutations are amiable to targeted therapy. the era of precision medicine assured new hopes for patient with unresectable cancer. there is some preliminary data that shows benefit of precision medicine in gb cancer as well. the estimation of targeted therapy relies on obtaining biopsy therapy on cancer which can often be challenging, associated with complication and less acceptable by the patients. studies in some other cancer shows that genetic mutation can be predicted based on imaging characteristics, however no such study has been done in gb cancer. the fundamental hypothesis is that prediction of her2 status and response to anti-her2 directed therapy using deep learning radiomic models in unresectable gbc will allow researchers to fully harness the potential of targeted therapy in clinical trials.

Eligibility criteria:
inclusion criteria: 1. patients with unresectable mass-forming gbc 2. patients willing to give informed consent exclusion criteria: 1. patients with prior chemotherapy for gbc 2. patients with deranged rfts 3. patients with contrast allergy

Keywords: gallbladder cancer, her2, radiogenomics, ct scan
circulating tumour cells as biomarkers to predict prostate cancer metastasis for treatment stratification of cancer

Conditions: Prostate Cancer

Summary: the goal of this study is to establish the value of circulating tumour cell (ctc) positivity in predicting post-rp treatment failure, including bcr and new lesions detected by cancer imaging. we plan to recruit participants who will undergo radical prostatectomy (rp). participants will have their blood samples taken just before surgery and 3 months after the surgery to test for ctcs. then participants will be followed-up for cancer progression information at 3 month intervals for the first year then yearly intervals after that. their psa will be observed over time.

this is a single site, double-blinded, prospective, paired cohort study. participating patients and clinicians involved in treatment or management will be blinded to the ctc results, to avoid influencing standard patient treatment, management, and progression outcomes after rp. patients will be recruited (months 1-24) at uclh, where the uk largest urological surgery centre is located and performs robot-assisted rp on pca patients referred from several regional hospitals. the clinical team at uclh will identify eligible patients who will be approached by the clinical research fellow (crf) employed on the research project or the clinical care team for informed consent using the consent forms specifically designed for this project for blood collection and future research. non-metastatic disease will be based on the current standard diagnostic imaging methods including ct/mri and psma-pet/bone scan. a pre-surgery psa test will be performed routinely at uclh. 2 x 10 ml blood samples will be collected (months 1-27) using the lavender cap edta tube according to our established method from each consented patient by the crf or the clinical care team at uclh during the pre- and post-rp psa test blood sampling, and taken to the laboratory at barts cancer institute, john vane science centre, charterhouse square either by the crf, a tissue bank acquisition officer (tbao)(in the absence of the crf) or the postdoc (anonymise samples transfer in the absence of crf and tbao) under the signed material transfer agreement (mta), at room temperature. the samples will be transported in designated sample carrier using a taxi service. no public transport is to be used for moving samples between sites.

Eligibility criteria:
inclusion criteria: * high/high intermediate risk non-metastatic risk localised pca based on the eau stratification system * scheduled for robot-assisted rp * informed consent exclusion criteria: * with other co-occurring cancers * neo-adjuvant adt * adjuvant adt
a phase 2 study of gc1102 (recombinant hepatitis b immunoglobulin) in hbv-related liver transplant recipients

Conditions: Hepatitis B Infection

Summary: this is a proof-of-concept study for gc1102 to demonstrate preventing the recurrence of hepatitis b virus (hbv) infection following liver transplantation and a dose-finding study to determine its optional dose.

gc1102 is a new recombinant hepatitis b immunoglobulin (hbig) from chinese hamster ovary (cho) cells. it is a monoclonal antibody and has high affinity and avidity to hepatitis b surface antigen and several advantages compared to hbig derived from blood plasma of human donors. forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000iu) of gc1102 or with high dose (80,000iu) and be followed up till 28 weeks.

Eligibility criteria:
inclusion criteria: * given written informed consent * aged 19 - 65 years * expected liver transplantation related to hepatitis b * positive hbsag exclusion criteria: * patients has participated in any other clinical trial within 30 days * patients who are scheduled re-operation for liver transplantation * patients with are co-infected with hav, hcv or hiv * history of malignant tumor within 5 years except primary liver cancer * patients with moderate or severe renal disorder (serum creatinine \> 1.5 x ulm) or anuria, acute renal failure or dialysis * patients who had experienced cardiovascular attack, myocardiac infarction, ptca or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months * history of anaphylaxis against active ingredient or excipients of study drug * patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months * patients who had been treated with any other immuno globulin within 3 months * pregnant or breast-feeding women * women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study * alcohol or drug abuse within 6 months * patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study

Keywords: hbv-related liver transplantation hepatitis b immuno globulin
dose response study of aerobic exercise in older adults

Conditions: Alzheimer's Disease

Summary: this is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. a total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. these exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. this is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.


Eligibility criteria:
inclusion criteria: * informed consent * age 65 years or older * underactive or sedentary based on the telephone assessment of physical activity * community dwelling with a caregiver willing to accompany the participant to visits to the screening evaluation. the caregiver must visit with the subject more than five times a week. * nondemented: clinical dementia rating (cdr) 0 * adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments * stable doses of medications for at least 30 days prior to screening. * likely to participate in all scheduled evaluations and complete the exercise program over 52 weeks exclusion criteria: * dementia * cdr \> 0 * current clinically significant major psychiatric disorder (e.g., major depressive disorder) according to diagnostic statistical manual (dsm)-iv criteria or geriatric depression score of 5 or greater. * significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study * current clinically-significant systemic illness likely to result in deterioration of the patient's condition or affect the patient's safety during the study * history of clinically-evident stroke * clinically-significant infection within the last 30 days * myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years. * uncontrolled hypertension within the last 6 months * history of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma) * history of drug or alcohol abuse as defined by dsm-iv criteria within the last 2 years * insulin-dependent diabetes mellitus * significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
behavioral economics for activity motivation in adolescents (beam)

Conditions: Type 2 Diabetes; PreDiabetes; Insulin Resistance; Polycystic Ovary Syndrome

Summary: there is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (aya) with type 2 diabetes (t2d), who often have very low levels of physical activity. the beam trial is a proposed mobile health (mhealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in aya with t2d and prediabetes.


Eligibility criteria:
inclusion criteria: * 1) males or females age 13 to 22 years. * 2) overweight or obese (bmi ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years) * 3) diagnosis with prediabetes or type 2 diabetes * 4) consent (subjects 18 and older), parental/guardian permission (subjects 13-17), assent (subjects 13-17) * 5) willingness to wear fitbit during waking hours daily for duration of run-in and intervention. * 6) possession of a smartphone. exclusion criteria: * 1) potential subject unable to speak or read in english * 2) severe cognitive impairment * 3) permanent or temporary physical disability that impairs ambulation or precludes engagement in mvpa * 4) current pregnancy * 5) previously-diagnosed or current restrictive or purging eating disorder * 6) moderate to vigorous physical activity (mvpa) \>30 minutes per day or fitbit wear \< 4 days during second week of 2-week run-in period
blood loss during cesarean section. comparing two techniques of blunt expansion of uterine incision: transversal vs. cephalad-caudad,

Conditions: Blunt Expansion of the Uterine Incision

Summary: obstetrical blood loss is an important reason of maternal morbidity and mortality. because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. the purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.


Eligibility criteria:
inclusion criteria: * singleton pregnancies * gestational age: 34 weeks or more * delivery by cesarean section * presurgical hemoglobin \> 10.5 g/dl exclusion criteria: * two or more previous cesarean sections * history of uterine rupture in a previous pregnancy * history of myomectomy * history of abdominal trauma with an uterine lesion * blood dyscrasia * multiple pregnancy * placenta previa * abruptio placenta * stillbirth * sharp uterine expansion

Keywords: uterine incision. blunt transversal expansion. blunt cephalad-caudad expansion.